Efficacy and Safety of AN2898 and AN2728 Topical Ointments to Treat Mild-to-Moderate Atopic Dermatitis

Pfizer

Status and phase: Completed; Phase 2

Conditions: Dermatitis, Atopic

Treatments: Drug: AN2898 ointment vehicle; Drug: AN2728 ointment, 2%; Drug: AN2898 ointment, 1%; Drug: AN2728 ointment vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01301508

C3471001 (Other Identifier)

AN2898-AD-202

Details and patient eligibility

About

The purpose of this study is to determine whether AN2898 and AN2728 ointments are safe and effective treatments for mild-to-moderate atopic dermatitis (AD).

Enrollment: 46 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of atopic dermatitis that has been clinically stable for ≥1 month
• Total body surface area (BSA) of atopic dermatitis involvement ≤35%, excluding involvement of the face, scalp, and groin
• Presence of two (2) comparable target lesions
• Willing and able to apply study medications as directed, comply with study instructions, and commit to attending all visits
• Females of childbearing potential must use at least one highly effective method of birth control. Males with partners of childbearing potential should inform them of their participation in this clinical study and use highly effective methods of birth control during the study.

Exclusion criteria

• Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period
• Active or potentially recurrent dermatologic condition other than atopic dermatitis in the target lesion area that may confound evaluation
• Significant confounding conditions as assessed by study doctor
• History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
• Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
• Pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups

AN2898 ointment, 1%, vs. ointment vehicle

Experimental group

Description:

AN2898 ointment applied twice daily for 6 weeks to one target lesion, and AN2898 ointment vehicle applied twice daily for 6 weeks to a second target lesion. Treatments will be randomly assigned to target lesions A and B.

Treatment:

Drug: AN2898 ointment vehicle

Drug: AN2898 ointment, 1%

AN2728 ointment, 2%, vs. ointment vehicle

Experimental group

Description:

AN2728 ointment applied twice daily for 6 weeks to one target lesion, and AN2728 ointment vehicle applied twice daily for 6 weeks to a second target lesion. Treatments will be randomly assigned to target lesions A and B.

Treatment:

Drug: AN2728 ointment vehicle

Drug: AN2728 ointment, 2%